The U.S. Food and Drug Administration (FDA) has recently issued an emergency use authorization (EUA) for certain sterilization systems that could potentially decontaminate up to 4 million N95 respirators or N95-equivalent respirators daily. By way of background, the surge of patients in healthcare facilities due to the COVID-19 pandemic has led to a decreased supply of certain personal protection equipment (PPE) (e.g., respirators and facemasks). Such PPE is necessary to protect healthcare providers on the frontlines from COVID-19. Therefore, the FDA has issued this EUA to ensure that frontline healthcare providers have access to critical PPE required to combat COVID-19. The EUA is effective until the FDA declares that circumstances no longer exist to justify the EUA, or it is revoked.
The FDA’s EUA authorizes certain Advanced Sterilization Products, Inc. (ASP) sterilization systems (i.e., STERRAD 100S, STERRAD NX and STERRAD 100NX) to be utilized by healthcare providers to sterilize N95 and N95-equivalent respirators for single user reuse. Note that N95 respirators containing cellulose-based materials are incompatible with the ASP STERRAD sterilization systems. Further, each sterilization system has a specific corresponding decontamination cycle. STERRAD 100S systems must be operated in STERRAD 100S Cycles, STERRAD NX systems must be operated in NX Standard Cycles and STERRAD 100NX systems must be operated in 100NX Express Cycles. These sterilization systems take from 24 to 55 minutes to decontaminate compatible respirators, depending on the sterilization system used. Each system is capable of reprocessing approximately 480 respirators per day. The FDA estimates that nearly 10,000 STERRAD sterilization systems exist in hospitals across the U.S.
The EUA also specifies limitations to the decontamination process. First, each decontaminated respirator must be utilized by the same healthcare provider who originally utilized the respirator. It specifically prohibits decontaminated respirators to be utilized by any healthcare provider other than the provider who originally wore it. Second, respirators may only go through the decontamination process a maximum of two (2) times. The FDA found that the decontamination process is effective to prevent exposure to COVID-19 for a maximum of two decontamination cycles per respirator.
If a facility decides to utilize an ASP sterilization system to decontaminate respirators, it must adhere to the EUA’s Scope of Authorization. The Scope of Authorization specifies that ASP sterilization systems are to be used with cleared and commercially available STERRAD cassettes, compatible sterilization pouches (e.g., Tyvek pouches with STERRAD Chemical Indicators), STERRAD Chemical Indicator Strips, SEALSURE Chemical Indicator Tape and VELOCITY Biological Indicator/Process Challenge Devices.
When decontaminating respirators, facilities should load the STERRAD sterilization system with compatible respirators. Any respirators that are visibly soiled or damaged should be immediately discarded. No more than ten (10) pouches may be loaded per sterilizer load. A Chemical Indicator or chemical indicator tape should be placed in the chamber to verify the respirators have been exposed to the sterilant. The decontamination process utilizes a hydrogen peroxide vapor to decontaminate the respirators. Once the sterilization cycle is complete, facilities must compare the chemical indicator to the “pass” reference color included with the chemical indicator. If the chemical indicator color matches the “pass” color, or is lighter, the respirators have been decontaminated. If the chemical indicator does not match the “pass” color, the respirator should be re-run through the decontamination cycle or discarded.
REQUIRED DOCUMENTATION FROM ASP
ASP must deliver the following documentation to each facility that notifies ASP that it intends to utilize one of its approved sterilization systems:
- Instructions for Healthcare Personnel: Preparation of compatible N95 respirators for decontamination in STERRAD Sterilization Systems (“Instructions for HCP”);
- Instructions for Healthcare Facilities: Decontamination of compatible N95 respirators in STERRAD Sterilization Systems (“Instructions for Healthcare Facilities”); and
- Fact Sheet for Healthcare Personnel: ASP STERRAD Sterilization Systems for Decontaminating Compatible N95 respirators (the “Fact Sheet”).
These documents include critical information and instructions for healthcare facilities to utilize ASP’s sterilization systems properly and efficiently when decontaminating respirators. Therefore, the FDA requires all facilities to obtain these documents prior to decontaminating any respirators.
HEALTHCARE FACILITY REQUIREMENTS
Prior to decontaminating any respirators, healthcare facilities must notify ASP that they intend to utilize an ASP STERRAD sterilization system for decontamination purposes. Upon receiving the notification, ASP will provide the facility with the Instructions for HCP, Instructions for Healthcare Facilities, and the Fact Sheet. Healthcare facilities that are decontaminating respirators must make the Fact Sheet available to all healthcare providers that may utilize a decontaminated respirator. Further, a facility must monitor its healthcare providers utilizing decontaminated respirators for any signs or symptoms of COVID-19. Should any signs or symptoms be found, the facility must promptly report such information to ASP.
Additionally, healthcare facilities must implement policies to track the number of times a compatible respirator has been decontaminated. The policies should also ensure that each decontaminated respirator is returned to its previous user. Healthcare facilities must also inspect each decontaminated respirator following the decontamination process. Any respirators with discoloration or other signs of degradation should be discarded and ASP should be promptly notified of such degradation. Each facility should maintain documentation of its use of ASP’s STERRAD sterilization systems consistent with current healthcare facility protocols
For more information regarding the FDA’s Emergency Use Authorization, please contact your regular HLP attorney, or Partners@thehlp.com, or call (212) 734-0128 or (248) 996-8510.